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Title

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Clinical Research Coordinator

Description

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We are looking for a dedicated and detail-oriented Clinical Research Coordinator to join our team. The ideal candidate will be responsible for managing and coordinating clinical research projects, ensuring compliance with regulatory requirements, and maintaining accurate and organized records. This role involves working closely with principal investigators, research staff, and participants to ensure the successful execution of clinical trials. The Clinical Research Coordinator will also be responsible for recruiting and enrolling participants, obtaining informed consent, and monitoring patient progress throughout the study. Additionally, the coordinator will be tasked with preparing and submitting regulatory documents, maintaining study documentation, and ensuring adherence to study protocols. Strong communication skills, attention to detail, and the ability to work independently are essential for this role. The successful candidate will have a background in clinical research, healthcare, or a related field, and will be familiar with Good Clinical Practice (GCP) guidelines and other regulatory requirements. This is an excellent opportunity for someone who is passionate about clinical research and is looking to contribute to the advancement of medical knowledge and patient care.

Responsibilities

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  • Coordinate and oversee clinical research projects and trials.
  • Ensure compliance with regulatory requirements and study protocols.
  • Recruit and enroll study participants.
  • Obtain informed consent from participants.
  • Monitor patient progress and collect data throughout the study.
  • Prepare and submit regulatory documents.
  • Maintain accurate and organized study documentation.
  • Communicate with principal investigators, research staff, and participants.
  • Conduct study visits and assessments.
  • Ensure adherence to Good Clinical Practice (GCP) guidelines.
  • Manage study budgets and resources.
  • Assist with data analysis and reporting.
  • Provide training and support to research staff.
  • Coordinate with external vendors and collaborators.
  • Ensure timely completion of study milestones.
  • Address and resolve any issues that arise during the study.
  • Maintain confidentiality and protect patient privacy.
  • Participate in study meetings and conferences.
  • Prepare study materials and supplies.
  • Stay updated on industry trends and best practices.

Requirements

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  • Bachelor's degree in a related field (e.g., healthcare, life sciences).
  • Previous experience in clinical research or a related field.
  • Knowledge of Good Clinical Practice (GCP) guidelines.
  • Strong organizational and time management skills.
  • Excellent communication and interpersonal skills.
  • Attention to detail and accuracy.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office and research software.
  • Familiarity with regulatory requirements and documentation.
  • Ability to handle multiple tasks and prioritize effectively.
  • Strong problem-solving skills.
  • Experience with patient recruitment and enrollment.
  • Knowledge of medical terminology and procedures.
  • Ability to maintain confidentiality and protect patient privacy.
  • Experience with data collection and analysis.
  • Ability to travel as needed for study visits.
  • Strong ethical and professional conduct.
  • Ability to work in a fast-paced environment.
  • Experience with electronic data capture systems.
  • Certification in clinical research (e.g., CCRC, CCRP) is a plus.

Potential interview questions

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  • Can you describe your experience with clinical research projects?
  • How do you ensure compliance with regulatory requirements?
  • What strategies do you use for recruiting and enrolling study participants?
  • How do you handle informed consent and patient confidentiality?
  • Can you provide an example of a challenging situation you faced during a study and how you resolved it?
  • How do you manage and organize study documentation?
  • What experience do you have with data collection and analysis?
  • How do you ensure adherence to study protocols and guidelines?
  • Can you describe your experience with Good Clinical Practice (GCP) guidelines?
  • How do you communicate and coordinate with research staff and participants?
  • What tools and software do you use for managing clinical research projects?
  • How do you handle multiple tasks and prioritize effectively?
  • Can you describe your experience with regulatory document preparation and submission?
  • How do you stay updated on industry trends and best practices?
  • What experience do you have with electronic data capture systems?
  • How do you ensure the timely completion of study milestones?
  • Can you describe your experience with patient monitoring and follow-up?
  • How do you provide training and support to research staff?
  • What experience do you have with managing study budgets and resources?
  • How do you address and resolve issues that arise during a study?